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EC number: 232-221-5 | CAS number: 7790-76-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Feb - 23 Jun 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dicalcium pyrophosphate
- EC Number:
- 232-221-5
- EC Name:
- Dicalcium pyrophosphate
- Cas Number:
- 7790-76-3
- Molecular formula:
- Ca2O7P2
- IUPAC Name:
- dicalcium pyrophosphate
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- his operon (S. typhimurium), trp operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 313, 625, 1250, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: distilled water was used as solvent/vehicle, since this medium is not suspected of chemical reaction with the test substance and is compatible with the survival of the bacteria and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-aminoanthracene (10-50 µg/plate)
- Remarks:
- with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- other: daunomycin (6 µg/plate); ICR 191 acridine (1 µg/plate)
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- INITIAL TEST
METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48-72 h
NUMBER OF REPLICATIONS: 3
CONFIRMATORY TEST
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertant colonies on the test plates compared to the solvent/vehicle control plates - Evaluation criteria:
- In general, a 2 or 2.5-fold increase in the number of revertant colonies per plate over the background (spontaneous revertant frequency) is used as a criterion to distinguish active mutagens from non-mutagenic materials. The presence of dose response is a further criterion for mutagenic materials.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: slight precipitation was seen at all test material concentrations, which did not influence the results of the assay
RANGE-FINDING/SCREENING STUDIES: A preliminary experiment was conducted to determine cytotoxicity and solubility of the test substance. Starting with the test material concentration of 5 mg/plate (recommended by OECD GL 471) and subsequent serial dilutions (ratio 1:2) following concentrations of test material were applied: 5, 2.5, 1.25, 0.625, 0.313 and 0.156 mg/plate on two bacteria strains (TA 98 and TA 1535) with different mutation type (frameshift and base-pair substitution) with and without metabolic activation.
The highest concentration of that solution was chosen for the main test that caused low cytotoxicity and/or where the precipitate did not interfere with the scoring according to OECD GL 471.
COMPARISON WITH HISTORICAL CONTROL DATA: The solvent and positive control values were acceptable and compatible with the historical control values.
Any other information on results incl. tables
Test Material concentrations:
Concentration 1: 5 mg/plate
Concentration 2: 2.5 mg/plate
Concentration 3: 1.25 mg/plate
Concentration 4: 0.625 mg/plate
Concentration 5: 0.313 mg/plate
Table 2:Mean plate counts and standard deviations (SD); strain: TA98
Controls/ test substance conc. |
Colony count |
|||
TA98 |
||||
Main test: Preincubation method |
Confirmatory test: Plate incorporation method |
|||
Mean |
SD |
Mean |
SD |
|
NK |
18 |
2 |
13 |
2 |
NK+S9 |
23 |
1 |
20 |
2 |
PK |
508 |
36 |
632 |
39 |
PK1+S9 |
2154 |
207 |
2032 |
116 |
PK2+S9 |
139 |
20 |
160 |
11 |
Conc. 1 |
18 |
4 |
14 |
2 |
Conc. 1+S9 |
21 |
2 |
23 |
4 |
Conc. 2 |
17 |
2 |
12 |
4 |
Conc. 2+S9 |
25 |
5 |
24 |
7 |
Conc. 3 |
20 |
3 |
16 |
8 |
Conc. 3+S9 |
30 |
4 |
16 |
3 |
Conc. 4 |
15 |
5 |
15 |
1 |
Conc. 4+S9 |
25 |
6 |
18 |
1 |
Conc. 5 |
22 |
4 |
12 |
3 |
Conc. 5+S9 |
27 |
6 |
23 |
3 |
Key:
SD – Standard deviation
NK - negative control
PK - positive control without S9 (daunomycin)
PK1 - positive control 1 with S9 (2-aminoanthracene)
PK2 - positive control 2 with S9 (benzo(a)pyrene)
Conc. - concentration
Table 3:Mean plate counts and standard deviations (SD); strain: TA100
Controls/ test substance conc. |
Colony count |
|||
TA100 |
||||
Main test: Preincubation method |
Confirmatory test: Plate incorporation method |
|||
Mean |
SD |
Mean |
SD |
|
NK |
82 |
1 |
87 |
16 |
NK+S9 |
100 |
10 |
96 |
4 |
PK |
508 |
52 |
775 |
202 |
PK1+S9 |
1966 |
109 |
1783 |
111 |
PK2+S9 |
686 |
77 |
724 |
95 |
Conc. 1 |
87 |
8 |
84 |
7 |
Conc. 1+S9 |
100 |
8 |
85 |
12 |
Conc. 2 |
100 |
10 |
79 |
11 |
Conc. 2+S9 |
103 |
5 |
93 |
8 |
Conc. 3 |
82 |
6 |
80 |
6 |
Conc. 3+S9 |
103 |
7 |
88 |
9 |
Conc. 4 |
90 |
8 |
82 |
2 |
Conc. 4+S9 |
97 |
2 |
94 |
16 |
Conc. 5 |
97 |
4 |
79 |
3 |
Conc. 5+S9 |
109 |
17 |
89 |
10 |
Key:
SD – Standard deviation
NK - negative control
PK - positive control without S9 (sodium azide)
PK1 - positive control 1 with S9 (2-aminoanthracene)
PK2 - positive control 2 with S9 (benzo(a)pyrene)
Conc. - concentration
Table 4:Mean plate counts and standard deviations (SD); strain: TA1535
Controls/ test substance conc. |
Colony count |
|||
TA1535 |
||||
Main test: Preincubation method |
Confirmatory test: Plate incorporation method |
|||
Mean |
SD |
Mean |
SD |
|
NK |
10 |
3 |
8 |
4 |
NK+S9 |
9 |
2 |
11 |
4 |
PK |
375 |
33 |
312 |
28 |
PK1+S9 |
82 |
10 |
47 |
17 |
Conc. 1 |
8 |
2 |
8 |
3 |
Conc. 1+S9 |
9 |
2 |
9 |
7 |
Conc. 2 |
10 |
4 |
8 |
4 |
Conc. 2+S9 |
5 |
4 |
10 |
0 |
Conc. 3 |
11 |
8 |
14 |
3 |
Conc. 3+S9 |
5 |
1 |
8 |
3 |
Conc. 4 |
8 |
6 |
9 |
3 |
Conc. 4+S9 |
7 |
2 |
6 |
2 |
Conc. 5 |
10 |
3 |
11 |
3 |
Conc. 5+S9 |
8 |
2 |
9 |
1 |
Key:
SD – Standard deviation
NK - negative control
PK - positive control without S9 (sodium azide)
PK1 - positive control 1 with S9 (2-aminoanthracene)
Conc. - concentration
Table 5: Mean plate counts and standard deviations (SD); strain: TA1537
Controls/ test substance conc. |
Colony count |
|||
TA1537 |
||||
Main test: Preincubation method |
Confirmatory test: Plate incorporation method |
|||
Mean |
SD |
Mean |
SD |
|
NK |
7 |
2 |
4 |
3 |
NK+S9 |
7 |
3 |
7 |
4 |
PK |
1635 |
439 |
122 |
15 |
PK1+S9 |
144 |
23 |
177 |
29 |
Conc. 1 |
7 |
4 |
6 |
3 |
Conc. 1+S9 |
6 |
5 |
5 |
1 |
Conc. 2 |
7 |
2 |
5 |
2 |
Conc. 2+S9 |
6 |
0 |
6 |
1 |
Conc. 3 |
6 |
1 |
7 |
1 |
Conc. 3+S9 |
10 |
2 |
6 |
1 |
Conc. 4 |
8 |
1 |
6 |
4 |
Conc. 4+S9 |
8 |
3 |
5 |
1 |
Conc. 5 |
6 |
3 |
3 |
2 |
Conc. 5+S9 |
10 |
2 |
7 |
5 |
Key:
SD – Standard deviation
NK - negative control
PK - positive control without S9 (ICR 191 acridine)
PK1 - positive control 1 with S9 (2-aminoanthracene)
Conc. - concentration
Table 6:Mean plate counts and standard deviations (SD); strain: WP2uvrA
Controls/ test substance conc. |
Colony count |
|||
WP2uvrA |
||||
Main test: Preincubation method |
Confirmatory test: Plate incorporation method |
|||
Mean |
SD |
Mean |
SD |
|
NK |
17 |
2 |
27 |
4 |
NK+S9 |
13 |
2 |
31 |
4 |
PK |
1000 |
30 |
1350 |
38 |
PK1+S9 |
402 |
31 |
357 |
44 |
Conc. 1 |
18 |
3 |
35 |
2 |
Conc. 1+S9 |
16 |
8 |
35 |
4 |
Conc. 2 |
17 |
5 |
35 |
3 |
Conc. 2+S9 |
16 |
4 |
29 |
2 |
Conc. 3 |
18 |
6 |
25 |
3 |
Conc. 3+S9 |
17 |
8 |
32 |
2 |
Conc. 4 |
16 |
1 |
26 |
5 |
Conc. 4+S9 |
16 |
1 |
36 |
11 |
Conc. 5 |
20 |
8 |
34 |
2 |
Conc. 5+S9 |
17 |
6 |
35 |
5 |
Key:
SD – Standard deviation
NK - negative control
PK - positive control without S9 (4-nitroquinoline-1-oxide)
PK1 - positive control 1 with S9 (2-aminoanthracene)
Conc. - concentration
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test material did not induce reverse gene mutations in Salmonella typhimurium (TA 98, TA 100, TA 1535 and TA 1537) or Escherichia coli (WP2 uvrA) tester strains. Therefore, the test material is considered to be not mutagenic in bacteria.
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